BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2949542 · Received January 11, 2013

    Report

    Report Number
    9610825-2012-00294
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 13, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED EVENT HAS BEEN REC'D FOR EVAL. THE INVESTIGATION ON THE DEVICE IS ON-GOING AT THIS TIME. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. THE PUMP HAS SOFTWARE VERSION (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: ON (B)(6) 2012 OVER INFUSION - PT IN LABOR - NO INJURY, PUMP SET TO INFUSE 2ML/HR OF OXYTOCIN. WHEN PUMP WAS STARTED, FLUIDS BEGAN TO FREE FLOW. PUMP DID NOT FREE FLOW DURING STANDBY MODE. ONCE REMOVED FROM STANDBY MODE TO STOP MODE, FREE FLOW STARTED AGAIN. INFUSION STARTED AT 11:17AM AND REMOVED FROM PT AT 11:23 AM. THEIR INVESTIGATION SHOWED FREE FLOW RATE OF 10 DROPS/30 SEC WITH A 10 DROP SET EQUATING TO 120ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17077 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other